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Peripheral Nerve Blocks for Above-the-knee Amputations

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ClinicalTrials.gov Identifier: NCT03404180
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Hyperglycaemia (Diabetic) Hypertension Coronary Artery Disease Pulmonary Disease, Chronic Obstructive Procedure: Peripheral nerve block Drug: Intravenous Sedatives Procedure: Lateral femoral cutaneous nerve blocks Procedure: Obturator nerve blocks Phase 4

Detailed Description:
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot clinical trial with a single arm
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Peripheral Nerve Blocks for Upper Leg Amputations
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peripheral nerve block

Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.

All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.

Procedure: Peripheral nerve block
All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed.

Drug: Intravenous Sedatives
Intravenous sedation using propofol or dexmedetomidine will be administered.
Other Name: Propofol or Dexmedetomidine

Procedure: Lateral femoral cutaneous nerve blocks
After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.

Procedure: Obturator nerve blocks
After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.




Primary Outcome Measures :
  1. Chi-squared tests of peripheral nerve block success as a primary anesthetic [ Time Frame: Changes from baseline through 30 days post-operative ]
    Differences in block success percentages analyzed between study participants.

  2. Analysis of pain scores [ Time Frame: Changes from baseline through 48 hours post procedure. ]
    Numerical rating scale pain scores (0-10) will be obtained from patients upon arrival and recorded hourly until discharge. Patients will be called or visited 24-48 hours post procedure to inquire about patient satisfaction. Differences in study participant pain scores will be examined through t-tests. P < 0.05 will be considered statistically significant.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Changes from baseline through 30 days post-operative ]
    The medical record will be reviewed to assess 30-day mortality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing above-the-knee amputation or knee disarticulation
  • Ability to understand and provide informed consent

Exclusion Criteria:

  • Patient refusal or inability to provide informed consent
  • True allergy, not sensitivity, to any of the following substances:
  • - Local anesthetics
  • - Propofol or other sedative agents
  • - General anesthetic agents
  • Pregnancy
  • Severe hepatic impairment
  • Evidence of infection at or near the proposed needle insertion site
  • Any sensorimotor deficit, whether acute or chronic, as determined by the PI
  • Chronic use of opioid medication
  • BMI ≥ 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404180


Contacts
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Contact: Amy M. Gunnett, RN, CCRC 352-273-8911 agunnett@anest.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
US Department of Veterans Affairs
Investigators
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Principal Investigator: José R Soberón, MD Malcom Randall VA Medical Center

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03404180     History of Changes
Other Study ID Numbers: IRB201702402
OCR18952 ( Other Identifier: University of Florida )
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Heart Diseases
Pulmonary Disease, Chronic Obstructive
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Hyperglycemia
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lung Diseases, Obstructive
Atherosclerosis
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents